CANADIAN VIGOUR CENTRE
Bridging hearts and minds to enhance cardiovascular care
Inside this issue: Letter 1 PW Armstrong
The Canadian Cardiac Chronicle Volume 17, No. 2
Fall 2013
Letter from Dr. Paul Armstrong: Recently I have been engaged with my colleagues at the Canadian VIGOUR Centre in creating our annual report for 2012, which celebrates CVC’s 15th year as an ARO (academic research organization), and a significant wealth of trial experience, along with peer reviewed publications and ample mentoring opportunities for our next generation of health researchers. The exercise of generating an annual report gives me pause to reflect on our collective contributions to date, but also to examine and articulate our future direction(s) as it relates to our overall role in the cardiovascular research arena in Canada and our raison d’être. As part of our annual faculty Advance (I avoid Retreats), we illustrated our organizational purpose and future direction into what we term the CVC Compass, as borrowed from the Harvard Business Review’s assessment of the Four Seasons Hotel approach. This compass is now displayed on the back cover of this edition of the Chronicle, in our latest annual report, as well as our web site (http://www.vigour.ualberta.ca/About.aspx). This exercise of “calibrating our compass”, that is, setting our objectives and strategic priorities, has helped us in reflecting on who we are and where we are headed. I also believe it will be useful to new staff and our community of investigators and many colleagues worldwide.
Trial Updates
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Although the term ARO is in common use, its meaning is less clear: ironically this is especially true for many of our colleagues within the university and health care environment. Four years ago I attempted a definition which still resonates and is referred to in our annual report. I include it here to remove unnecessary ambiguity:
Monitoring
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CVC News
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“An ARO in my view possesses scholarly values of inquiry and truth, shares knowledge in an ethical framework, is dedicated to enhancing public health, and values discovery, novel approaches and methodologies over profit. It strives to achieve the operational efficiency of a CRO (contract research organization) and is directly linked to patient care and the bedside. It is almost always embedded in a university, functions on a not-for-profit basis, is committed to the education of the next generation of professionals and fulfills its contract with society by emphasizing the public good.”
CVC Publications
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In these challenging times for clinical research, collaborators are key to a preferred future. Our faculty has been significantly strengthened by the addition of Shaun Goodman from the University of Toronto who is also an Adjunct Professor of Medicine at the University of Alberta. Shaun is now playing a leadership role in two of our major CVC trials described elsewhere in the Chronicle and is actively engaged in our overall activities. This development signals a new east-west Canadian axis in clinical research. A key responsibility Shaun holds, as the Heart & Stroke Foundation Polo Chair, is to assist in mentoring young clinical investigators, a commitment we enthusiastically share. We continue and have recently enriched our long standing collaboration with the Duke Clinical Research Institute, now led by Eric Peterson. This north-south axis is key to the future of our collaborative North American research endeavors as an ARO and fundamental to where our compass points. As this edition of the Chronicle takes flight, our attention turns to the Canadian Cardiovascular Society meeting in Montreal October 17-20th where our PROACT work will unfold and the American Heart Association meeting in November where new insights from STREAM into aborted MI, the approach to rescue coronary intervention and the much anticipated one year follow up, will be presented. We invite our many friends and co-investigators to join us during the 19th annual Beyond 2000 symposium to be held Thursday morning October 17, 2013 and look forward to seeing them participate in what promises to be a terrific program as noted in this edition of the Chronicle. For more information on the Beyond 2000 symposium, please go to the website www.beyond2000.org. With kind regards,
CVC is proud to be a University of Alberta Centre
Paul W. Armstrong, MD
www.vigour.ualberta.ca
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The Canadian Cardiac Chronicle
IMPROVE-IT
IMProved Reduction of Outcomes: Vytorin Efficacy International Trial Sponsored by Merck & Co. Inc., (previously ScheringPlough Research Institute) this trial is a multicenter, double-blind, randomized study to establish the clinical benefit and safety of Vytorin (ezetimibe/ simvastatin Tablet) vs. simvastatin monotherapy in high-risk patients presenting with acute coronary syndrome. ClinicalTrials.gov Identifier: NCT00202878
The IMPROVE-IT trial is projected to reach the protocol-defined number of clinical endpoints in 2014. Patient retention continues to be paramount to ensuring we reach our target number of endpoints. The countdown is on as we head towards the finish line! In preparing the database for study closure, Memo #408 recently came out, where QC of AEs and potential clinical endpoints is being conducted. Your cooperation in addressing any of these important “AEQC” data queries within 10 days is appreciated. Reminders: (1) CVC no longer tracks REB submissions/ acknowledgements of external SAEs. Though sites must submit external SAEs to their REBs, per their REB guidelines, they no longer need to send copies of their REB correspondence to CVC for these external safety reports. This documentation should be filed at your site. (2) Should a patient permanently discontinue study drug, please remember to make the withdrawal call in IVRS as well. Data Clean Up – Commendations to the following sites that have achieved 100% clean data as of Sep06’2013:
2052 – Vancouver General Hospital, PI—Dr. Wong, SC - Naomi Uchida
STABILITY STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY Sponsored by Glaxo SmithKline, this trial is a randomized, placebocontrolled, double-blind, parallel group, multicenter, event-driven clinical outcomes study of darapladib versus placebo in subjects with chronic coronary heart disease to compare the incidence of major adverse cardiovascular events. ClinicalTrials.gov Identifier: NCT00799903
Thanks to all our Canadian sites who have been working hard toward study closeout and quickly answering any outstanding queries. As we work to close-out the regulatory files for the study, remember if you have not already submitted your end of study financial disclosure forms and ethics study closeout letters please email or fax them to us now at 780-492-0613. We will be doing one final review/reconciliation of the files and contacting you to collect any of the final documents that we may be missing. This is an exciting time for the trial as we all anticipate the presentation of the results in the near future. For further information, please contact Assistant Director, Clinical Trials, Tracy Temple at 1-800-707-9098 Option 5 or by email at tracy.temple@ualberta.ca.
2054 – Surrey Memorial Hospital, PI—Dr. Cheung, SC - Tracy Cleveland
2067 – Scarborough Cardiology Research, PI—Dr. Mukherjee, SC - Kim Brown
2071 – Yamaska (CSSSHY), PI—Dr. Brossoit, SC - Celine Peck
2075 – Montreal General Hospital, PI—Dr. Huynh, SC - Barbara St. Jacques
2080 – Hôpital Pierre Le Gardeur, PI—Dr. Gosselin, SC - Margaux David
2089 – Hôpital Laval, PI—Dr. DeLarochelliere, SC - Melanie Roy
2090 – St. Catharines Hospital, PI—Dr. Pallie, SC - Sheila Krekorian
2098 – Hôtel-Dieu de Lévis, PI—Dr. Grondin, SC - Noella Bilodeau
CEC Adjudicated Events – please remember to submit any outstanding (de-identified) source documents to the CEC. For further information, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098, ext. 3 or by email at jodi.parrotta@ualberta.ca.
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Volume 17, No. 2
EXSCEL It has been a busy few months for the EXSCEL trial. Global enrollment is now over 7900 with Canada having enrolled 293 patients. Canada currently has 24 sites activated and we are excited to announce that we are planning for an upcoming expansion of 5 new Canadian sites. The Amendment 4 transition is now well underway with the first wave of Canadian sites already successfully transitioned. Our goal is to have all sites transitioned by the end of October; to that end we will continue to work closely with our sites. Please remember that prior to transitioning, all regulatory documents must be in order and all study staff must have received appropriate training. If you have any questions or concerns related to the transition process, please contact the Project Team. Thank you for all your hard work in cleaning up the study data prior to the data lock on August 30th in preparation for the next DSMB meeting in October. We were able to achieve 94% site clean data. A special thank you to those sites achieving 100% site clean data:
Vancouver General Hospital, PI—Dr. T. Elliott, SC - Marla Inducil
Fraser Clinical Trials, PI—Dr. R. Kuritzky, SC - Carol Marchand
Centre de Cardiologie et de Recherche Clinique de Laval, PI—Dr. Y. Robitaille, SC - Christine Masson
St. Michael’s Health Centre, PI—Dr. L. Leiter, SC - Danielle Bedard
McMaster University, PI—Dr. Z Punthakee, SC - Irene Stanton
Institut Universitaire de Cardiologie et de Pneumologie de Québec, PI—Dr. F. Dube, SC - Marilène Bolduc
Clinical Trial Unit at the University of Calgary, PI—Dr. R. Sigal, SC - Mary Ann Clearwaters
Congratulations to our top five recruiters as of September 5th 2013:
Dr. Ronald Bourgeois, Moncton NB – 38 pts
Dr. Thomas Elliott, Vancouver BC – 26 pts
Dr. Richard Dumas, Laval QC – 23 pts
Dr. Ron Sigal, Calgary AB – 20 pts
Dr. Vincent C. Woo, Winnipeg MB – 21 pts
The data from the patients enrolled in 2011/2012 will be presented at the Canadian Cardiovascular Congress in Montreal on
Sponsored by Amylin Pharmaceuticals, Inc. this trial is a pragmatic, long term, placebo-controlled, double-blinded trial which seeks to characterize the effects of exenatide once weekly on cardiovascular (CV) -related outcomes in patients with type 2 diabetes when added to the current usual care for glycemic control in a standard care setting. ClinicalTrials.gov Identifier: NCT01144338
As a reminder Courtney Bryden will be starting her maternity leave on Sept 19 and Amanda Carapellucci has stepped in as her replacement over the next year. Moving forward please contact Amanda and Diane for all trial related questions. We would like to thank Courtney for all her hard work on EXSCEL and wish her all the best. (See Amanda’s bio on page 6 announcements.) We thank you for your continued support of the EXSCEL trial! For further information please contact Clinical Trial Project Lead, Amanda Carapellucci at 1800-707-9098 (Ext 2) or by email at amanda.carapellucci@ualberta.ca or Diane Camara at 1-800-725-6585 or by email at dcamara@chrc.net.
PROACT—A local initiative After careful consideration of the protocol in early 2013, it was decided that modifications to the protocol and trial processes were necessary. Input was received from many trial collaborators and the next phase was initiated in July 2013. We are pleased to report that the updated processes made a smooth transition and as of 27 September 2013, 116 patients have been randomized.
Exenatide Study of Cardiovascular Event Lowering
October 20, 2013 @ 0930 by Dr. Justin Ezekowitz - “Providing Rapid Out Of Hospital Acute Cardiovascular Treatment (PROACT-3): Insights from the Field”. For further information please contact Paula Priest at 1-800-707-9098 (ext 9) or email at paula.priest@ualberta.ca.
PROACT Providing Rapid Out of Hospital Acute Cardiovascular Treatment An Edmonton-region local initiative sponsored by the University Hospital Foundation and the Mazankowski Alberta Heart Institute. Additional support for point of care meters provided by Alere Inc. ClinicalTrials.gov Identifier: NCT01634425
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The Canadian Cardiac Chronicle
ODYSSEY OUTCOMES Sponsored by Sanofiaventis Recherche & Développement this is a randomized, double-blind, placebo-controlled, parallel -group study to evaluate the effect of SAR236553/ REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an Acute Coronary Syndrome. ClinicalTrials.gov Identifier: NCT01663402
The ODYSSEY Outcomes study is now well underway around the world with over 900 patients randomized. In Canada we have activated over 20 sites and are looking forward to seeing screening and recruitment efforts increase throughout the next couple months at all sites. Congratulations to Dr. Ronald Bourgeois and the team (Sub-Investigator, Dr. Daniel Landry; Study Coordinators Glenda Shea-Landry, Jennifer Lambert and Karen Boyd) at G.A. Research Associates in Moncton, NB for screening and randomizing the first patient in Canada! This is a significant milestone for the study in Canada and many thanks for all your hard work! We would also like to acknowledge the following sites that we have added to the “first patient randomized list” for the study. Keep up the great work!
Dr. James Cha, Judy Otis and Elizabeth Burke in Oshawa, ON
Dr. Manohara Senaratne, Robin Varughese and Denali Perera in Edmonton, AB
Dr. Christopher Lai and Marnie Jarvis in Thunder Bay, ON
Dr. Paul MacDonald and Joy Howard in Sydney, NS
Dr, Jan Kornder, Dale Kastanis and Lynn Breakwell in Surrey, BC
We will be working hard to get the remainder of our sites activated in the next few months. Don’t forget to get all your training complete and regulatory in while you are waiting on contracts and ethics! We would like to send out the challenge to all of our sites to put all eyes on ODYSSEY over that next month and let’s see how many patients we can find in Canada! For those sites that have now screened and/or randomized a patient, don’t forget to complete your CRF’s and answer any open queries. We have had many great questions over the last several months, especially from those of you starting to screen and recruit patients. Keep them coming and watch for FAQ’s in the newsletters and updates sent out to you throughout the trial. We are still recruiting a few final sites for this study so if you are interested in hearing more about ODYSSEY Outcomes or if you are a site and have questions regarding ODYSSEY Outcomes please contact Robert Evans at robert.evans@ualberta.ca or 1-800-707-9098 Option 1.
REGULATE PCI Sponsored by Regado Biosciences Inc. this is a randomized, open-label, multi-center, activecontrolled, parallel group study to determine the efficacy and safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention Clinical trials.gov Identifier: NCT01848106
CVC is buzzing with excitement on this long awaited PCI trial, as we work to start up 20 centres across Canada and enroll over 13,000 patients globally in the next couple years. Hats off to Dr. Warren Cantor and his Study Coordinator Kim Robbins with the York PCI Group in Newmarket, ON for a record start up. They are not only the first site activated in Canada but one of the first 4 sites activated for the trial. Only a couple days after receiving study drug we are pleased to share that they have already recruited 5 patients. Thanks to them and their team at York PCI for all their hard work to make this happen. We have had a tremendous response from our
Canadian sites on this study and are now actively working through start-up with the plan to have many of our Canadian sites activated over the next couple months. If you are one of our participating sites, we will be working with you to ensure all ethics submissions are in by mid-Oct. Please email your regulatory documents for review as they become completed. We look forward to seeing some of our investigators and study coordinators next month in Chicago for our first investigator meeting. For further information, or if you are interested in participating, please contact Clinical Trial Project Lead, Jodi Parrotta at 1-800-707-9098, ext. 3 or by email at jodi.parrotta@ualberta.ca.
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Volume 17, No. 2
TECOS With the expected study end date on target for the latter part of 2014, the pressure is on to maintain or improve our patient retention numbers and to clean up data! Our Canadian TECOS sites have done an excellent job of retaining patients in the study and keeping our withdrawn consent or lost to follow-up numbers low. We do, however, need to be vigilant about the number of patients permanently discontinuing study drug. It is essential that Principal Investigators are involved in any decision to discontinue study drug and that these decisions are welldocumented at the site. You have put such tremendous effort into the TECOS study over the last several years we want to ensure that the end result is meaningful! The Inform data complete and clean rates in Canada continue to be impressive at 98% to 99%. One of the main data priorities now as we near the finish line is to ensure that data is being entered in a timely manner after visits so that the Project Team can keep a close eye on patients that may be at risk for becoming lost to follow-up. The other priority is to ensure that CEC queries are being taken care of quickly and thoroughly. TECOS is a cardiovascular outcomes driven trial and will
continue until the required CV events have been accrued . The Clinical Events Committee must receive all of the appropriate information – all required source documents provided and requests for additional data needed, before adjudication can be completed. We can’t do this without your help! Congratulations to the following sites that have 100% clean data!
Dr. Sigalas & Darlene Hutton – Rouge Valley Metabolic Research Associates, Scarborough, ON
Dr. Yale & Mylene Roy – Royal Victoria Hospital, Montreal, QC
Dr. Saunders & Lori Richert – Rivergrove Medical Clinic, Winnipeg, MB
Sponsored by Merck & Co. Inc., TECOS is a Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. ClinicalTrials.gov Identifier: NCT00790205
A TECOS rejuvenation meeting is in the planning stages and will likely occur this November. Please keep an eye out for further communications coming via email in the near future. For further information, please contact Clinical Trial Project Lead, Lyndsey Garritty at 1-800-707-9098, ext 4 or via email at lyndsey.garritty@ualberta.ca.
GUIDE-IT GUIDE-IT is just getting warmed up after the summer months. The first Canadian site has been activated and we look forward to the first patient being enrolled momentarily with many more to come! Congratulations to our first active site! Dr. Patricia Campbell, Kim Ronak and Sheilah Heal at University of Calgary/ Foothills Hospital in Calgary, Alberta. Site Initiation Visits are complete and lab kits have arrived on site, so with only a few sitespecific regulatory items outstanding we are projecting that the remainder of our Canadian sites will be ready to enroll within weeks. The U.S. has enrolled over 80 patients and Canada is eager to contribute to this number over the coming months. Protocol Amendment 1 has been distributed and for those sites that are still in the ethics review stages for this amendment, please re-
member that waivers for the revised patient eligibility criteria are available if required. The GUIDE-IT website is an invaluable resource for study documents and materials, training and education items, study updates and frequently asked questions. Please don’t be shy about accessing this tool when needed! Thank you to all of our GUIDE-IT sites for your commitment to participate in this important heart failure study. We are looking forward to working with each of you closely to make this trial a success! For further information, please contact Clinical Trial Project Lead, Lyndsey Garritty at 1-800-707-9098, ext 4 or via email at lyndsey.garritty@ualberta.ca.
In collaboration with DCRI (Duke Clinical Research Institute) GUIDE-IT is a prospective, randomized 1:1, multi-centre clinical trial GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure ClinicalTrials.gov Identifier: NCT01685840
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The Canadian Cardiac Chronicle
Monitoring
New Concepts in Acute Coronary Syndromes Presenters: • Paul Armstrong, MD • Frans Van de Werf, MD • Robert Welsh, MD • Christopher Buller, MD • Shaun Goodman, MD • Valerie Desjardins, MD • Darren McGuire, MD • Justin Ezekowitz, MD
While we often cringe when we hear the word “audit” cross our path, we have also come to realize that with each audit we are involved in we learn new things and become better at what we do. We are always keen to share these insights with you and hope that you can implement some, if not all of them, into your organizations now rather than when the auditor dials up your number. Here are a few tips to implement into your practice so you are ready for that next audit:
Ensure all staff participating in the study at your site are trained on (1) the protocol, (2) any amendments, (3) GCP and Health Canada Division 5, (4) transportation of dangerous goods, (5) specimen collection, and any other trial specific processes prior to performing study procedures. Ensure you have certificates and documentation for each staff member who will be working on the trial and make sure that the trainer at your site is the one documenting the topics of discussion and not the trainee. All training should be current.
In addition to having site SOP’s, for each study that you participate in you should have documented processes that are specific for that trial. For example, if study drug is required to be refrigerated, what is your process once the drug is delivered to your office, what is the process that you will follow for temperature excursions, and what is the process in the event of a power outage? Other processes can include things like where are subjects going to be seen in the clinic, and how will blood specimens be handled and shipped.
Ensure you have calibration and maintenance documentation of equipment such as thermometers, blood pressure machines, scales, ECG’s, centrifuge, etc. Keep all records and make sure your calibration and maintenance documents are current.
Whether you work in a hospital or clinic and have electronic medical records, you should have validation documentation that includes how often it is validated as well as how and when the records are backed up and stored.
Agenda: • The Future of ST Elevation Myocardial Infarction Care: One Size Does Not Fit All • The Need for Rescue PCI After Failed Fibrinolysis: Who, When and Why? • Modulating the Oculogyric Reflex in Acute Coronary Syndromes: Insights from a Veteran • Triple Antithrombotic Therapy in ACS: Navigating the Quagmire • Diabetes and Acute Coronary Syndromes: An Evidence-based Approach • Acute Heart Failure – ACS in Wolves’ Clothing? Challenges and Opportunities • The Future of Clinical Trials in ACS: More with Less?
With monitoring related questions please contact Lead CRA, Halina Nawrocki at 1-905896-7292 or by email at halina.nawrocki@rogers.com.
CVC News The CVC would like to welcome and introduce you to our new team members: Amanda Carapellucci joined the CVC in August to fill in as Project Lead on the EXSCEL trial during Courtney Gubbels maternity leave. Her background includes a BSc in Biological Sciences and several years of experience in research administration and oncologic clinical trials. Yvonne Regnier joined CVC in August as Dr. Armstrong's Executive Assistant. Yvonne has extensive senior level office administration experience in both the private and public sector, as well as diverse editorial experience in the research arena in the Human Nutrition Research Group at the University of Alberta.
Kalli Belseck joined the CVC team back in June, filling the role as our Administrative Assistant. She is a recent graduate with a BA, majoring in Anthropology. Kalli is becoming more involved with the clinical operations team and will be supporting them on the trials with her initial focus on PROACT, IMPROVE-IT and REGULATE PCI.
Volume 17, No. 2
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Selected CVC Presentations and Publications Since Last Issue Leonardi S, Tricoci P, White HD, Armstrong PW, Huang Z, Wallentin L, Aylward PE, Moliterno DJ, Van de Werf F, Chen E, Providencia L, Nordrehaug JE, Held C, Strony J, Rorick TL, Harrington RA, Mahaffey KW. Effect of Vorapaxar on Myocardial Infarction in the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER) Trial.Eur Heart J 2013; 34 (23): 1723-31. http://dx.doi.org/10.1093/eurheartj/eht104. Rose JJ, Newby LK, Broderick S, Chiswell K, Van de Werf F, Armstrong PW, Mahaffey KW, Harrington RA, Ohman EM, Giugliano RP, Goodman SG, White HD, Califf RM, Granger CB, Lopes RD. Left bundle branch block in non-ST segment elevation acute coronary syndromes: incidence, angiographic characteristics and clinical outcomes. J Am Coll Cardiol. 2013; 13: 1461–1463. http://dx.doi.org/10.1016/ j.jacc.2012.12.032 (Letter to Editor). Guptill JT, Mehta RH, Armstrong PW. Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: Timing, Characteristics, and Clinical Outcomes (APEX-AMI) Circ Cardiovasc Interv. 2013;6: 176-83. http://dx.doi.org/10.1161/ CIRCINTERVENTIONS.112.000159. Lopes RD, White JA, Atar D, Keltai M, Kleiman NS, White HD, Widimsky P, Zeymer U, Giugliano RP, Tricoci P, Braunwald E, Bode C, Ohman EM, Armstrong PW, Newby LK. Incidence, treatment, and outcomes of atrial fibrillation complicating non-STsegment elevation acute coronary syndromes. Int J Cardiol. 2013 Apr 8. http://dx.doi.org/ 10.1016/ j.ijcard.2013.03.037 (online publication). Klutstein MW, Westerhout CM, Armstrong PW, Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S, Widimsky P, Steg PG, Dalby A, Zeymer U, Van de Werf F, Harrington RA, Newby LK, Rao SV. Radial versus femoral access, bleeding and ischemic events in patients with non-ST-segment elevation acute coronary syndrome managed with an invasive strategy. Am Heart J. 2013 Apr;165(4):583-90. http:// dx.doi.org/10.1016/j.ahj.2013.01.009. Epub 2013 Feb 22. Kaul P, Ezekowitz JA, Armstrong PW, Leung BK, Savu A, Welsh RC, Quan H, Knudtson ML, McAlister FA. Incidence of heart failure and mortality after acute coronary syndromes. Am Heart J. 2013;165(3):379-85. http://dx.doi.org/10.1016/ j.ahj.2012.12.005. van Diepen S, Newby LK, Lopes RD, Stebbins A, Hasselblad V, James S, Roe MT, Ezekowitz JA, Moliterno DJ, Neumann FJ, Reist C, Mahaffey KW, Hochman JS, Hamm CW, Armstrong PW, Granger CB, Theroux P; on behalf of the APEX AMI Investi-
gators. Prognostic relevance of baseline pro- and anti-inflammatory markers in STEMI: An APEX AMI substudy. Int J Cardiol. 2013 Feb 7. http:// dx.doi.org/10.1016/j.ijcard.2013.01.004 [Epub ahead of print]. Tricoci P, Leonardi S, White J, White HD, Armstrong PW, Montalescot G, Giugliano RP, Gibson CM, Van de Werf F, Califf RM, Harrington RA, Braunwald E, Mahaffey KW, Newby LK. Cardiac Troponin after Percutaneous Coronary Intervention and 1-Year Mortality in NSTE ACS Using Systematic Evaluation of Biomarker Trends. J Am Coll Cardiol. 2013; 62(3); 242–251. http:// dx.doi.org/10.1016/j.jacc.2013.04.043. Lopes RD, Lokhnygina Y, Hasselblad V, Newby KL, Yow E, Granger CB, Armstrong PW, Hochman JS, Mills JS, Ruzyll W, Mahaffey KW. Methods of creatine kinase-MB analysis to predict mortality in patients with myocardial infarction treated with reperfusion therapy. Trials 2013, 14:123 epublication http://www.trialsjournal.com/ content/14/1/123; (PMID 23782531) http:// dx.doi.org/10.1186/1745-6215-14-123. Nicolau JC, Corbalan R, Rafael Diaz R, Bahit C, Armstrong PW, Granger CB, Lopes RD. Cardiovascular clinical research in South America. Am Heart J 2013;165:848-53. http://dx.doi.org/10.1016/ j.ahj.2013.02.004. Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper KS, Van de Werf F, Armstrong PW, Mahaffey KW, Harrington RA, Diaz R, Ohman M, White HD, James S, Granger CB. Heart Failure Complicating Non–ST-Segment Elevation Acute Coronary Syndrome: Timing, Predictors, and Clinical Outcomes. J Am Coll Cardiol HF 2013;1:223–9. http:// dx.doi.org/10.1016/j.jchf.2013.02.007. Zannad F, Garcia AA, Anker SD, Armstrong PW, Calvo G, Cleland JGF, Cohn JN, Dickstein K, Domanski MJ, Ekman I, Filippatos GS,Gheorghiade M, Hernandez AF, Jaarsma T, Koglin J, Konstam M, Kupfer S, Maggioni AP, Mebazaa A, Metra M, Nowack C, Pieske B, Piña IL. Pocock SJ, Piotr Ponikowski P, Rosano G, Ruilope LM, Ruschitzka F, Severin T, Solomon S, Stein K, Stockbridge NL, Stough WG, Swedberg K, Tavazzi L, Voors AA, Wasserman SM, Woehrle H, Zalewski A, McMurray JJV. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. Epublication (PMID: 23787718) http:// dx.doi.org/10.1093/eurjhf/hft095. Alherbish A, Westerhout CM, Fu Y, White HD, Granger CB, Wagner G, Armstrong PW. The Forgotten Lead: Does aVR ST-deviation Add Insight into the Outcomes of STEMI Patients? Am Heart J
If you have received the chronicle electronically and would like a hard copy, please email us at: thecvc@ualberta.ca
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Articles Continued... Address for Inquiries or Submission of Articles of Interest: 2-132 Li Ka Shing Centre for Health Research Innovation University of Alberta Edmonton, AB T6G 2E1 Canada Phone: 1-800-707-9098 Fax: (780) 492-0613 www.vigour.ualberta.ca
Publication Information This newsletter is published periodically as a service to Canadian investigational sites. The purpose is to provide information of interest to individuals involved in cardiovascular clinical trials managed by the Canadian VIGOUR Centre, University of Alberta in Edmonton, Alberta, Canada.
The VIGOUR (Virtual Coordinating Centre for Global Collaborative Cardiovascular Research) group is an international academic group committed to advancing cardiovascular medicine and enhancing patient care worldwide. Its membership includes: the Canadian VIGOUR Centre (CVC), University of Alberta, Edmonton, Alberta, Canada; Green Lane Coordinating Centre, Auckland, New Zealand; National Health & Medical Research Council – Clinical Trials Centre, Sydney, Australia; Flinders Medical Centre, Bedford Park, Australia; Duke Clinical Research Institute (DCRI), Duke University, Durham, NC, USA; Leuven Coordinating Centre, University Hospital Gasthuisberg, Leuven, Belgium; ECLA, Rosario, Argentina, South America; TANGO, Buenos Aires, Argentina, South America; Uppsala Clinical Research Centre, Uppsala, Sweden
2013; 166: 333-9. (PMID: 2389517) http:// dx.doi.org/10.1016/j.ahj.2013.05.018. Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong PW, Starling RC, McMurray JJ, Massie BM, Swedberg K, Ezekowitz JA, Fonarow GC, Teerlink JR, Metra M, Whellan DJ, O’Connor CM, Califf RM, Hernandez AF Do Countries or Hospitals With Longer Hospital Stays for Acute Heart Failure Have Lower Readmission Rates? Findings From ASCEND-HF. Circ Heart Fail. 2013;6:727-732. http://dx.doi.org/10.1161/ CIRCHEARTFAILURE.112.000265 ( Editor’s Pick). Roe MT, Goodman SG, Ohman EM, Stevens SR, Hochman JS, Gottlieb S, Martinez F, Dalby AJ, Boden WE, White HD, Prabhakaran D, Winters KJ, Aylward PE, Bassand JP, McGuire DK, Ardissino D, Fox KA, Armstrong PW. Elderly Patients with Acute Coronary Syndromes Managed Without Revascularization: Insights into the Safety of Long-Term Dual Antiplatelet Therapy with Reduced-Dose Prasugrel versus Standard-Dose Clopidogrel. Circulation. 2013 2013;128:823-33. (PMID: 23852610) http://dx.doi.org/10.1161/ CIRCULATIONAHA.113.002303. Howlett JG, Ezekowitz JA, Podder M, Hernandez AF, Diaz R, Dickstein K, Dunlap ME, Corbalán R. Armstrong PW, Starling RC, O’Connor CM, Califf RM, Fonarow GC; on behalf of the ASCEND-HF Investigators Global Variation in Quality of Care Among Patients Hospitalized With Acute Heart Failure in an International Trial Findings From the Acute Study Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial (ASCEND-HF). Circ Cardiovasc Qual Outcomes. 2013;6: on line publication http:// dx.doi.org/10.1161/ CIRCOUTCOMES.113.000119. van Diepen S, Vavalle JP, Newby LK, Clare R, Pieper KS, Ezekowitz JA, Hochman JS, Mahaffey KW, Armstrong PW, Granger CB. The Systemic Inflammatory Response Syndrome in Patients With ST-Segment Elevation Myocardial Infarction. Crit Care Med. 2013 Jun 11. [Epub ahead of print] PMID:23760155. Wiviott SD, White HD, Ohman EM, Fox KAA, Armstrong PW, Prabhakaran D, Hafley G, Lokhnygina Y, Boden WE, Hamm C, Clemmensen P, Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P, Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for patients with unstable angina or non-ST-segment elevation myocardial infarction with or without angiography: a secondary, prespecified analysis of the TRILOGY ACS trial. Lancet 2013;382:605-13 (PMID:23953385) http://dx.doi.org/10.1016/ S0140-6736(13)61451-8.
"Notice the outer ring of the compass is framed by four phrases we believe capture the context of our work; (i) leading hearts and minds which links with our logo of “bridging” hearts and minds, reflecting our earnest efforts to provide thought leadership to research so as to maximize its impact to cardiovascular patients (ii) continuously innovating or exploring new paths to enhance the care of our patients but also finding new and better way of doing things (iii) ensuring our work has impact on the cardiovascular health and on health policy and (iv) career development of our most valuable resource, namely our people. Now working from inside the compass, our purpose is central, and as equally well known are CVC’s vision and core values, which were the product of a prior Advance, and remain steadfast and relevant today. The two new quadrants are occupied by our promise which is what commitments we aim to keep in fulfilling our purpose and finally what operational priorities we propose moving forward." Acknowledgments to our Sponsors: Alere Inc. Amylin Pharmaceuticals, LLC GlaxoSmithKline Inc. Hoffmann-La Roche Merck & Co.,Inc. Regado Biosciences Inc. Sanofi-aventis Recherche & Développement Canadian Cardiac Chronicle Editorial Board: PW Armstrong Kalli Belseck Courtney Bryden Amanda Carapellucci Robert Evans Lyndsey Garritty Halina Nawrocki Jodi Parrotta
Dianne Payeur Paula Priest Tracy Temple